Z-1134-2022 Class II Terminated
FDA device recall Z-1134-2022 was initiated by ConvaTec, Inc on Apr 22, 2022 and is designated Class II. Reason for recall: Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears. The recall status is terminated (terminated Mar 4, 2026). Affected quantity: 600 market units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 1, 2022
- Initiation Date
- Apr 22, 2022
- Termination Date
- Mar 4, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 600 market units
Product Description
SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
Reason for Recall
Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.
Distribution Pattern
Distributed nationwide to NJ, PA, OH, CA, AL, MI, NY, TX, FL, NC, VA, LA, IL, DE, KY, WA, KS, MN, MS and internationally to India.
Code Information
Product order number: ICC 413157; LOT Number 1H02899; Expiration Date: Aug 2026; DI Number: 00768455106189